May 28, 2008 - The Medicines Company (NASDAQ: MDCO) announced receipt of a not approvable letter from the U.S. Food and Drug Administration (FDA) on a supplemental New Drug Application (sNDA) for an additional dosing regimen for Angiomax(R) (bivalirudin) in the treatment of acute coronary syndromes (ACS) initiated in the emergency department.
The primary basis of the filing was the ACUITY trial, whose results have been published in New England Journal of Medicine, Journal of the American Medical Association and Lancet. The Company believes that the ACUITY results are consistent with those demonstrated in clinical trials of over 47,000 patients across a broad spectrum of cardiovascular risk, including: REPLACE-2, BAT, and most recently, the HORIZONS-AMI trial. These trials demonstrate that utilizing Angiomax instead of heparins not only provides comparable protection against ischemic events but also reduces bleeding and costs.
The details can be read here.
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